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FDA 510(k)

OXYGEN MASK-HIGH CONCENTRATION

K-Number: K790165 · 1979-02-06

ApplicantAirlife, Inc.
Decision Date1979-02-06
Product CodeBYG
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

OXYGEN MASK-HIGH CONCENTRATION is the device name listed in this FDA 510(k) record. The listed applicant is Airlife, Inc.. It received FDA 510(k) clearance on 1979-02-06 under 510(k) number K790165. The device is classified under product code BYG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OXYGEN MASK-HIGH CONCENTRATION?

OXYGEN MASK-HIGH CONCENTRATION is a medical device that received FDA 510(k) clearance on 1979-02-06. The listed applicant is Airlife, Inc.. The 510(k) number is K790165.

When did OXYGEN MASK-HIGH CONCENTRATION receive FDA 510(k) clearance?

OXYGEN MASK-HIGH CONCENTRATION received FDA 510(k) clearance on 1979-02-06, under 510(k) number K790165.

Who is the listed applicant for OXYGEN MASK-HIGH CONCENTRATION?

The FDA 510(k) record lists Airlife, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OXYGEN MASK-HIGH CONCENTRATION?

The FDA product code for OXYGEN MASK-HIGH CONCENTRATION is BYG.

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Other records listing Airlife, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K834573AQUA TRAPK834570VOLUME VENTILATOR CIRCUIT W/WATER TRAPK834077SINGLE USE NEBULIZER-ADJUST-AIR ENTRAINK833196VOLUME VENTILATOR CIRCUIT-NEBULIZERK833197TRACH SWIVE/CONNECTORK832725DUAL DIAL VENTURI STYLE MASK

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Related Devices (Code: BYG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K963298FIRST AID KIT(S)Vector, Inc.K962848HANS RUDOLPH NASAL CPAP MASKHans Rudolph, Inc.K945482DISPOSABLE, CPAP OXYGEN MASKFvtnksK953464WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASKWestmed, Inc.K953039VARIOUS ADULT & CHILD HIGH CON/NONREBREATH OXY MASKSDadsun Corp., Ltd.K945472WESTMED PEDIATRIC AND ADULT AEROSOL MASKWestmed Intl.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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